Pharmacokinetic Solidarity? [BE/BA News]

posted by Helmut Homepage – Vienna, Austria, 2019-04-02 13:00  – Posting: # 20113
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Furthermore, the EMA is considering the FDA’s definition as laid down in CFR21§320.23(a)(1) for locally acting drugs

[…] scientifically valid measurements intended to reflect the rate and extent to which the active ingredient or active moiety becomes available at the site of action.
(my emphasis)

and will require biopsies as of April 1st, 2022.
—
Cheers,
Helmut Schütz
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